NCT01393353

Brief Summary

The study evaluates a computerized cognitive therapy in patients with Parkinson's disease who have a mild cognitive impairment or mild dementia. The control group is "trained" using Nintendo Wii. The main outcome parameter is a neuropsychological evaluation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 15, 2014

Status Verified

December 1, 2014

Enrollment Period

2.9 years

First QC Date

July 6, 2011

Last Update Submit

December 12, 2014

Conditions

Mental Competence

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological parameters: Tests of episodic memory, working memory, executive functions, visio-construction

    Neuropsychological tests: mini mental status (MMS), Clock drawing test, Boston Naming Test, Calculating, Semantic Fluency, Phonematic Fluency, California Verbal Learning Test, Corsi Block Tapping Test, Trail Making Test, Digit Span, Testbatterie zur Aufmerksamkeitsprüfung (alteredness, Working Memory, Divided Attention, Flexibility), Wisconsin Card Sorting Test, Apraxias, 5 Points Test, Mosaik Test

    Neuropsychological assessment immediatly before and after the training and 6 month later

Study Arms (2)

Computer game

SHAM COMPARATOR

Nintendo Wii

Other: computer game

Cognitive Training with Cogniplus

EXPERIMENTAL

CogniPlus

Other: Cognitive Training

Interventions

Cognitive TrainingOTHER
Cognitive Training with Cogniplus
computer gameOTHER
Computer game

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's disease and mild cognitive impairment (MCI) or mild dementia

You may not qualify if:

  • Moderate or severe dementia, other pathologies of the brain, physical conditions that prevent the participation, unsufficient knowledge of german, pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Peter Fuhr, Prof.

    University Hospital Basel, Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2011

First Posted

July 13, 2011

Study Start

May 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 15, 2014

Record last verified: 2014-12

Locations

CH(1)